Abstract
BackgroundFor standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015. The 89 terminologies were developed independently by 13 industry associations, suggesting that there may be inconsistencies among the terms proposed. The purpose of this study was to integrate the 89 sets of terminologies and evaluate inconsistencies among them using SPARQL.MethodsIn order to evaluate the inconsistencies among the integrated terminology, the following six items were evaluated: (1) whether the two-layer structure between category term and preferred term is consistent, (2) whether synonyms of a preferred term are involved. Reversing the layer-category order of matching was also performed, (3) whether each preferred term is subordinate to only one category term, (4) whether the definitions of terms are uniquely determined, (5) whether CDRH-NCIt terms corresponding to preferred terms are uniquely determined, (6) whether a term in a medical device problem is used for patient problems.ResultsAbout 60% of the total number of duplicated terms were found. This is because industry associations that created multiple terminologies adopted the same terms in terminologies of similar medical device groups. In the case that all terms with the same spelling have the same concept, efficient integration can be achieved automatically using RDF. Furthermore, we evaluated six matters of inconsistency in this study, terms that need to be reviewed accounted for about 10% or less than 10% in each item.ConclusionsThe RDF and SPARQL were useful tools to explore inconsistencies of hierarchies, definition statements, and synonyms when integrating terminolgy by term notation, and these had the advantage of reducing the physical and time burden.
Highlights
For standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015
Yagahara and Yokoi BMC Medical Informatics and Decision Making (2022) 22:16 terminology items for groups of Japanese medical device nomenclatures developed by 13 industry associations (Table 1) who are members of The Japan Federation of Medical Devices Associations (JFMDA), and these 89 terminology items are collectively named the JFMDA terminology
The 13 Japan industry associations independently each developed the terminologies using a bottom-up approach by gathering the terms used regularly in medical facilities to facilitate communication between medical staff and medical device manufacturers
Summary
For standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015. For the standardization of terms, The Ministry of Health, Labour and Welfare of Japan announced official terms for use with Japanese medical devices in the event of adverse events in March 2015 [1]. Any heterogeneity of the JFMDA terminology may lead to inaccurate report analysis and interpretations of results This makes it necessary to perform an accurate and detailed auditing of the terminology. Since there are few experts for auditing terminology in the JFMDA, it is to provide a continuous cycle including the automatic creation of inconsistency lists and considerations for terminology improvement
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